Apellis Pharmaceuticals (APLS) said Friday the Food and Drug Administration will review its new eye-disease drug in February, and APLS stock surged.
The new review date is actually a delay at Apellis’ behest. Earlier this month, Apellis said it planned to send 24-month test data from studies called Derby and Oaks in its request for approval of the drug, dubbed pegcetacoplan. Pegcetacoplan is being developed for patients with geographic atrophy, a progressive disease that impacts vision and often leads to blindness.
The submission counts as a “major amendment” to Apellis’ original request, which had the FDA slated to make a decision on pegcetacoplan this month. Now, the FDA will review the drug Feb. 26.
APLS Stock: Better Launch Position
The move is a complete turnaround from when Apellis first announced its plans to include the 24-month data in an updated submission. Then, APLS stock crashed 16%.
Apellis says it’s taking the delay to allow for a better launch position.
“With the inclusion of the 24-month data, we have the potential to have the best product profile at launch for pegcetacoplan, with minimal impact to launch timing,” Chief Executive Cedric Francois said in a written statement.
Researchers tested patients with every-other-month and monthly doses of pegcetacoplan. Recipients showed “increasing and consistent effects,” Apellis said in its news release. The company plans to ask the European Union to sign off on the eye-disease drug by the end of the year.
Shares Have Middling Ratings
Apellis shares crashed below their 200-day moving average earlier this month when the company announced its updated plans for the eye-disease treatment. Now, APLS stock looks likely to open near that line, according to MarketSmith.com.
Follow Allison Gatlin on Twitter at @IBD_AGatlin.
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